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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Thyroid-Stimulating Hormone
510(k) Number K860813
Device Name MICROMEDIC HTSH MONOCLONAL IRMA KIT
Applicant
Micromedic Systems
102 Witmer Rd.
Horsham,  PA  19044
Applicant Contact DEBORAH L LINDEMUTH
Correspondent
Micromedic Systems
102 Witmer Rd.
Horsham,  PA  19044
Correspondent Contact DEBORAH L LINDEMUTH
Regulation Number862.1690
Classification Product Code
JLW  
Date Received03/04/1986
Decision Date 07/14/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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